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Table 2 Effect of treatment (modified intention-to-treat) on primary and secondary outcomes (n = 88)

From: Long-term efficacy and cost-effectiveness of blended cognitive behavior therapy for high fear of recurrence in breast, prostate and colorectal Cancer survivors: follow-up of the SWORD randomized controlled trial

 

bCBT (n = 45)

CAU (n = 43)

 

Mean

SE/SD*

Mean

SE/SD*

Mean difference

95% CI

p value

Primary outcome

 FCR (CWS)

  T0

19.622

3.737

19.558

3.744

   

  T1 unadjusted

14.814

4.579

18.487

3.986

   

  T1 adjusted

14.743

0.432

18.277

0.454

−3.534

−4.764 to −2.305

0.000

  T2 unadjusted

13.718

4.472

17.844

3.836

   

  T2 adjusted

13.916

0.493

18.020

0.534

−4.104

−5.531 to − 2.677

0.000

  T3 unadjusted

14.684

4.539

16.516

4.081

   

  T3 adjusted

14.783

0.504

16.570

0.549

−1.787

−3.251 to −0.323

0.017

Secondary outcomes

 Multidimensional aspects of FCR

  Severity (FCRI)

   T0

21.909

4.850

23.116

6.456

   

   T1 unadjusted

16.605

7.251

22.282

5.991

   

   T1 adjusted

16.989

0.756

21.330

0.788

−4.341

−6.497 to −2.185

0.000

   T2 unadjusted

15.025

6.897

21.313

5.171

   

   T2 adjusted

15.957

0.688

20.462

0.742

−4.505

−6.513 to −2.497

0.000

   T3 unadjusted

15.842

7.343

19.733

5.539

   

   T3 adjusted

16.599

0.805

19.023

0.879

−2.423

−4.785 to −0.062

0.044

Distress, depression, anxiety

 Distress (HADS)

  T0

14.089

7.836

15.209

8.911

   

  T1 unadjusted

9.951

8.402

17.131

9.519

   

  T1 adjusted

10.749

0.731

16.003

0.763

−5.254

−7.334 to −3.174

0.000

  T2 unadjusted

9.718

7.412

15.862

9.771

   

  T2 adjusted

11.139

0.806

14.897

0.898

−3.759

−6.134 to −1.383

0.002

  T3 unadjusted

9.778

8.292

14.889

9.390

   

  T3 adjusted

11.414

0.966

13.228

1.082

−1.813

−4.669 to 1.043

0.213

 Anxiety (HADS)

  T0

8.156

4.101

8.395

4.914

   

  T1 unadjusted

5.317

4.239

9.447

5.012

   

  T1 adjusted

5.639

0.437

8.951

0.456

−3.312

−4.555 to −2.068

0.000

  T2 unadjusted

5.333

4.132

8.862

5.585

   

  T2 adjusted

6.030

0.528

8.549

0.588

−2.519

−4.074 to −0.964

0.002

  T3 unadjusted

4.944

4.056

8.333

4.844

   

  T3 adjusted

5.751

0.570

7.734

0.638

−1.984

−3.667 to − 0.301

0.021

 Depression (HADS)

  T0

5.933

4.218

6.814

4.722

   

  T1 unadjusted

4.634

4.598

7.684

5.152

   

  T1 adjusted

5.050

0.424

7.131

0.442

−2.081

−3.286 to −0.876

0.001

  T2 unadjusted

4.385

4.017

7.000

4.751

   

  T2 adjusted

5.042

0.418

6.406

0.467

−1.363

−2.597 to −0.130

0.030

  T3 unadjusted

4.833

4.675

6.556

4.956

   

  T3 adjusted

5.582

0.504

5.611

0.565

−.029

−1.520 to 1.462

0.970

 Cancer-specific distress (IES)

  T0

23.044

14.555

24.902

15.604

   

  T1 unadjusted

14.732

14.998

26.026

17.747

   

  T1 adjusted

15.539

2.064

24.598

2.208

−9.059

−15.003 to −3.115

0.003

  T2 unadjusted

9.973

13.710

16.643

15.905

   

  T2 adjusted

11.127

2.085

17.107

2.391

−5.979

−12.215 to 0.256

0.060

  T3 unadjusted

14.944

14.633

18.259

15.294

   

  T3 adjusted

15.781

2.147

17.254

2.450

−1.473

−7.883 to 4.938

0.653

 Fatigue (CIS-8R)

  T0

30.222

12.951

36.116

12.585

   

  T1 unadjusted

25.250

11.535

36.684

13.001

   

  T1 adjusted

27.961

1.137

33.478

1.176

−5.516

−8.771 to −2.262

0.001

  T2 unadjusted

26.769

11.855

32.586

12.290

   

  T2 adjusted

28.694

1.297

30.512

1.444

−1.818

−5.658 to 2.022

0.353

  T3 unadjusted

26.806

11.436

30.556

13.042

   

  T3 adjusted

29.387

1.350

26.888

1.514

2.499

−1.522 to 6.521

0.223

Quality of life (EORTC QLQ-C30)

 Global quality of life

  T0

62.222

19.672

61.434

20.252

   

  T1 unadjusted

73.062

19.402

57.479

20.483

   

  T1 adjusted

72.504

2.556

58.075

2.682

14.429

7.153 to 21.705

0.000

  T2 unadjusted

72.083

21.229

62.500

21.792

   

  T2 adjusted

71.918

3.004

62.632

3.264

9.286

0.576 to 17.997

0.037

  T3 unadjusted

73.026

19.609

65.278

19.948

   

  T3 adjusted

72.672

2.823

67.742

3.108

4.930

−3.331 to 13.192

0.242

 Physical functioning

  T0

87.704

13.406

83.953

16.269

   

  T1 unadjusted

89.380

11.735

80.855

20.010

   

  T1 adjusted

87.552

1.527

82.886

1.606

4.666

.296 to 9.037

0.036

  T2 unadjusted

88.750

15.148

86.458

14.809

   

  T2 adjusted

86.246

1.737

87.766

1.893

−1.519

−6.583 to 3.545

0.557

  T3 unadjusted

89.649

13.924

84.301

14.560

   

  T3 adjusted

87.986

1.592

86.829

1.721

1.156

−3.479 to 5.792

0.625

 Role functioning

  T0

77.037

26.181

74.806

25.295

   

  T1 unadjusted

85.659

21.076

74.123

23.474

   

  T1 adjusted

84.543

2.963

75.547

3.142

8.996

0.503 to 17.489

0.038

  T2 unadjusted

83.750

23.415

82.292

21.972

   

  T2 adjusted

82.766

3.407

82.705

3.742

0.061

−9.887 to 10.008

0.991

  T3 unadjusted

89.035

17.013

84.409

23.148

   

  T3 adjusted

87.388

2.777

85.357

3.043

2.031

−6.095 to 10.157

0.624

 Emotional functioning

  T0

64.815

22.883

66.860

22.456

   

  T1 unadjusted

81.589

23.185

60.256

29.830

   

  T1 adjusted

81.647

2.934

59.978

3.078

21.669

13.326 to 30.011

0.000

  T2 unadjusted

80.208

22.463

61.719

28.544

   

  T2 adjusted

78.959

3.259

60.785

3.540

18.174

8.731 to 27.617

0.000

  T3 unadjusted

77.851

23.592

68.548

25.973

   

  T3 adjusted

77.507

2.987

68.668

3.242

8.839

0.179 to 17.499

0.046

 Cognitive functioning

  T0

72.963

24.692

68.992

25.350

   

  T1 unadjusted

80.620

19.897

62.393

28.541

   

  T1 adjusted

79.977

2.920

64.662

3.071

15.315

6.989 to 23.641

0.000

  T2 unadjusted

82.500

19.954

72.917

28.945

   

  T2 adjusted

80.130

3.276

74.990

3.593

5.140

−4.421 to 14.701

0.292

  T3 unadjusted

79.386

22.738

68.280

25.587

   

  T3 adjusted

76.994

3.171

71.780

3.442

5.214

−4.013 to 14.441

0.268

 Social functioning

  T0

80.000

23.192

71.318

24.754

   

  T1 unadjusted

89.922

17.495

76.923

26.384

   

  T1 adjusted

87.868

2.907

79.225

3.055

8.643

0.306 to 16.979

0.042

  T2 unadjusted

85.833

22.504

80.208

22.175

   

  T2 adjusted

83.302

3.052

81.127

3.310

2.176

−6.727 to 11.078

0.632

  T3 unadjusted

88.158

19.723

86.022

19.292

   

  T3 adjusted

85.924

2.556

89.059

2.759

3.135

−10.641 to 4.370

0.413

  1. NOTE. Linear mixed-effects models were used to calculate all p-values. Adjusted means were adjusted for the baseline covariates primary cancer site and baseline value of the corresponding outcome; unadjusted means were unadjusted for covariates. Boldface type indicates a statistically significant effect for adjusted means (p < 0.05)
  2. *SEs are reported for adjusted means, SDs for unadjusted means
  3. Abbreviations: bCBT blended cognitive behaviour therapy, CAU care as usual; FCR fear of cancer recurrence, CWS Cancer Worry Scale, FCRI Fear of Cancer Recurrence Inventory, HADS Hospital Anxiety and Depression Scale, IES Impact of Events Scale, CIS-8R Checklist Individual Strength 8R, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, SD standard deviation, SE standard error